Low Postoperative Complications with On-X Valve
Clinical Study Reinforces Low Postoperative Complications with On-X Valve
AUSTIN, TX — June 25, 2003 — Medical Carbon Research Institute, L.L.C. (“MCRI”), manufacturer of the On-X(R) Prosthetic Heart Valve, announced the presentation of clinical study results comparing rates of late complications (thrombosis, major bleeding and major thromboembolism) for the On-X valve and competing valves within a poorly anticoagulated South African cohort of patients.
The results of the study were presented at the recent 23rd Meeting of the Society of Cardiac Surgeons, June 8-11, 2003 at Magog (Québec), Canada, by M. A. Williams F.R.C.S. (Ed) of the Provincial Hospital in Port Elizabeth, South Africa. The complete study report has been submitted to the Journal of Cardiac Surgery.
FINDINGS:
The study concludes that “The On-X valve has shown remarkable absence of valve thrombosis.” This conclusion is based on a study of 526 patients, 200 of which received the On-X valve. The On-X valves were implanted between 1999 and 2002. The mean follow-up on the On-X patients was 2.4 years and the maximum was 3.3 years. The On-X group was comprised of patients with varying amounts of anticoagulation. Approximately 58% of the patients in the On-X group were considered to have “satisfactory” anticoagulation, 23% were categorized as “unsatisfactory” anticoagulation and 19% had “no” anticoagulation. The unsatisfactory and no anticoagulation was due to poor patient compliance to established protocols.
In spite of the high incidence of unsatisfactory and no anticoagulation, the patients receiving On-X mitral valves experienced 0.0%/ptyr thrombosis, bleeding and thromboembolism. Patients receiving On-X aortic valves had 0.0%/ptyr thrombosis and bleeding and 1.8%/ptyr thromboembolism.
“We are extremely gratified by the outcome of this clinical study,” says Jack Bokros PhD, MCRI’s President. “These data suggest that the On-X valve behaves differently from other mechanical heart valves and can provide superior outcomes even in poorly anticoagulated populations.”
PATENTED PURE CARBON KEY TO THE SUCCESS OF THIS VALVE:
“What makes the On-X valve unique is the patented pure carbon material developed exclusively for this valve and the low pressure gradient / low turbulence made possible by the valve’s hemodynamic design,” Bokros also added. “The study provides empirical evidence that the On-X valve may have crossed a threshold, leaving behind the anticoagulation-related complications associated with other mechanical valves and the limited life of animal tissue valves ”
Mechanical valves post-operative anticoagulation includes the use of warfarin. Although warfarin has a long history of safe use, it has the potential side effects of bleeding and tissue necrosis. Most animal tissue valve recipients require aspirin for anticoagulation; while a minority still require the use of warfarin. Unlike mechanical valves, tissue valves have a fixed useful life and the potential of re-operation for patients that outlive the functional life of their valve.
MCRI TO INITIATE A NEW CLINICAL STUDY:
“Based on the excellent clinical results obtained using the On-X valve in Europe, North America and this South African study, MCRI is initiating a new clinical study, intended to define the lower limits for anticoagulation for the On-X valve. The study protocol has received European ethics committee approval,” remarked John Ely, MCRI’s Executive Vice President Regulatory Affairs.
ABOUT THE COMPANY:
MCRI distributes the On-X valve worldwide through regional and national distributors and competes in the $400 million heart valve replacement market.
FOR FURTHER INFORMATION, PLEASE CONTACT:
Clyde Baker
Exec VP Global Sales “ Marketing
MCRI -On-X Heart Valves
8200 Cameron Rd Ste A-196
Austin TX USA 78754-3823
512-339-8000 ext 269 phone
512-657-2214 cell phone
512-339-3636 fax
cbaker@mcritx.com
http://www.mcritx.com
On-X Life Technologies, Inc. (On-X LTI) was formerly Medical Carbon Research Institute (MCRI).
